Associate I, Quality Control

Moderna

Posted 12 days ago

Full Time

Norwood, Massachusetts

In Person

Smart Summary

The role involves performing in-process and release testing for raw materials, drug substance, and mRNA drug products in compliance with cGMP, while collaborating on method transfers and expanding Bioassay lab capabilities like sequencing and qPCR. Responsibilities also include investigating technical issues, supporting equipment qualification, representing the team in meetings, and mentoring junior analysts.

We are looking for a QC Analyst to ensure the quality of raw materials, drug substance, and mRNA drug products. A BS in Biochemistry and 0-2 years of experience is required, along with a demonstrated aptitude to learn GxP regulations. This is an excellent opportunity to contribute to Moderna's QC operations and work at the forefront of mRNA science.

Must Have Skills for ATS

In-Process Testing

Release Testing

cGMP Compliance

Method Transfers

Method Qualification

Sequencing

qPCR

Lab Operational Systems

Continuous Improvement

Audit Preparation

Regulatory Compliance

Deviation Investigations

Equipment Qualification

On-the-Job Training

SOP Writing

Data Integrity

Job Description

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

As a QC Analyst within the Bioassay team at Moderna’s Norwood site, you will play a critical role in ensuring the quality of raw materials, drug substance, and mRNA drug products through robust in-process and release testing. You’ll collaborate closely with management and technical teams to uphold high-quality standards in compliance with cGMP, contribute to laboratory operations and method implementation, and support both commercial and clinical programs. This is a high-impact opportunity for a technically skilled professional seeking to strengthen Moderna’s QC operations while working at the forefront of mRNA science. You will also have the opportunity to work closely with Generative AI tools as part of ongoing digital transformation and innovation initiatives within the QC organization.

Here’s What You’ll Do

Your key responsibilities will be:

  • Performing in-process and release testing for raw materials, drug substance, and mRNA drug products in compliance with cGMP requirements.

  • Generating critical testing data in support of both commercially approved products and clinical studies.

  • Collaborating with development teams for method transfers and qualification, expanding QC Bioassay lab capabilities including sequencing and qPCR.

  • Supporting the development, implementation, and maintenance of lab operational systems.

  • Leading or contributing to the execution of continuous improvement projects across the QC Bioassay function.

  • Participating in audit preparation and ensuring regulatory compliance for the lab.

Your responsibilities will also include:

  • Investigating and resolving technical issues, assay performance concerns, and equipment-related challenges.

  • Conducting deviation investigations and supporting technical assessments.

  • Assisting in equipment qualification, validation, and maintenance activities.

  • Representing the QC Bioassay team in the absence of management and participating in Tier meetings and resource scheduling.

  • Providing on-the-job training (OJT) and acting as a mentor for junior analysts.

  • Writing and revising SOPs, protocols, and technical reports with adherence to Good Documentation Practices (GDP).

  • Ensuring data integrity, training compliance, and execution of tasks according to SOPs and internal guidelines.

  • Responding to CTU alarms and contributing to a safe, inclusive, and collaborative laboratory culture.

The key Moderna Mindsets you’ll need to succeed in the role:

  • “We obsess over learning. We don’t have to be the smartest – we have to learn the fastest.”
    Your success in this role will depend on a constant drive to expand technical expertise, especially in complex assays and evolving quality control technologies. You'll adapt quickly to new data, regulatory changes, and innovation opportunities – including leveraging AI-enabled lab tools and automation.

  • “We behave like owners. The solutions we’re building go beyond any job description.”
    As a Senior QC Analyst, you won’t just complete tasks — you’ll own the quality systems and improvements you’re a part of. You’ll actively shape workflows, mentor peers, and elevate the lab’s performance, embodying full accountability for results and impact.

Here’s What You’ll Need (Basic Qualifications):

  • Education: BS in a relevant scientific discipline (Biochemistry)

  • Experience: 0-2 years of experience

  • Demonstrated aptitude or ability to learn: Able gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards and guidance’s.

  • This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

  • At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

  • Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs

  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support

  • Family planning benefits, including fertility, adoption, and surrogacy support

  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown

  • Savings and investment opportunities to help you plan for the future

  • Location-specific perks and extras

The salary range for this role is $53,500.00 - $85,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Our Working Model 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.  Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. 

Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1

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Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762).

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